Identity
- Trade Name
- ALTECH EUDAMED
- Device Name
- DOUBLE LINE/DOUBLE LUMEN BREATHING CIRCUIT (Non-Sterile) EUDAMED
- Model / Reference
- AL-1101-210.V001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +M485AL1101210V0011L EUDAMED
- Basic UDI-DI
- ++M485BCNS0010ZU EUDAMED
- Direct Marketing DI
- +M485AL1101210V0011L EUDAMED
- EMDN Code
- R02010101 BREATHING CIRCUITS, W/O WATER TRAP EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Altech by Meditera Tıbbi Malzeme Sanayi ve Ticaret A.Ş. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++M485BCNS0010ZU | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Meditera Tıbbi Malzeme Sanayi ve Ticaret A.Ş.
- EUDAMED SRN
- TR-MF-000014943
Sources (1)
- EUDAMED 8b93e5e1-3e87-436b-9ce3-1e1ea511c5a3 61 fields · synced Jun 18, 2026